A Regional Look at Grower Challenges and Engagement GMUS-3 Montreal, Quebec, Canada A Regional Look at Grower Challenges and Engagement Australia Jodie Pedrana Hort Innovation R&D Manager - Minor Use Tuesday, October 3rd, 2017

Through innovation, Hort Innovation strives to increase the productivity,  farm gate profitability and global competitiveness of Australia’s horticulture industries.

Hort Innovation Minor-Use Program Facilitates Strategic Agrichemical Review Process (SARP) Data generation projects to support minor-use APVMA Permit applications Contact for permits/label extensions with the APVMA & Registrants Maintains database of industry permits/applications/data Provides updates to industry.

Some of the Challenges Industry Face Market Failure - Limited access to new or existing pesticides Timelines to gain access - permits / label registrations / new chemistry High cost of new pesticides Increased environmental and OH&S regulations Restrictions and / or loss of pesticides Maximum Residue Limit (MRL) / residue issues / violations Market requirements - Export New and emerging pests & diseases Pesticide resistance Consumer expectations

Pesticide Registration Challenges – Market Failure The Australian market represents only 1-2% of the global pesticide market Market often fails to provide access to suitable registered pesticides for many use patterns (small market & low return on investment) Problematic cost/benefit to register minor use when full data packages are required Prolonged timeframes can be involved to secure a minor use registration

APVMA National Permit System The APVMA’s National Permit System adds some flexibility to the approval process and provides a legal framework that can allow access to products for minor-use purposes To issue an off-label permit, the APVMA must be satisfied the proposed use will be effective and will not have any adverse effects on humans, the crops, the environment and where relevant trade

Permit Applications To satisfy the APVMA an application has to have addressed the statutory criteria (safety, efficacy & trade), by using one, or a combination, of the following methods: Providing relevant data (efficacy & safety, residues & trade, OH&S & environment) Providing a valid scientific argument (extrapolation) Using overseas data assessments and decisions

Minor-Use Permits APVMA Registration Statistics Approx. 2/3 of the total volume of pesticides used in Australia is in grain crops APVMA receives about 250 permit applications per year, 40% are for renewals 900-1000 permits are currently in force 80-90% are for generic products 60% of applications are for horticulture; 10-15% are for broad acre crops 85% of applications have no trial data submitted and are assessed without provision of new data 85% of minor use applications require residue trial data to be provided for renewal 2/3 of new plant commodity MRLs come from minor use permits

APVMA Decision Issue of a permit –Notification plus any requirements for permit renewal How long is a permit issued for? - Minor-Use (3 years) with data requirements for renewal - Minor-Use (4 -10 years) no outstanding data requirements - Emergency Use-Permit (period necessary) - Research Permits (1 to 2 years)

Export / Trade and Chemical Review Challenges Disparate approaches to MRL setting domestically and for import tolerances between countries; Varied processes for gaining import tolerances Data assessments Fees and data requirements Who can apply Timelines for assessments Differing default MRL’s Differing commodity classifications Countries can have different approaches to MRL setting. At a national/domestic level residue definitions can vary which can make ensuring compliance potentially problematic. Then there is the issue of differing default MRLs. There is also the issue of differing national commodity classifications, as not everyone uses the Codex system. So there can sometimes be confusion over exactly what commodity a national/domestic MRL covers. A similar situation occurs with regards to the ways in which countries go about setting import tolerances. Firstly, data requirements can vary immensely. Some countries can require efficacy, residue and tox data plus copies of labels to be submitted. Others little or no data provided there is a Codex MRL (in the absence of a domestic MRL). Then there is the issue of process, i.e., to whom should the application be made (some countries both the Ag and Health ministries are involved) and what language is acceptable for the application, then there are timeframes and the fees that can be involved. From a grower industry perspective, seeking an import tolerance could be a nightmare, particularly for small industries.

Export Compliance Negative Lack of or different use patterns leading to different MRL’s Can preclude use in export crops Positive Where Codex MRLs recognised/adopted

Import Tolerances Negative Gaining an import tolerance can be complex, expensive and difficult to achieve (data requirements, fees etc) Positive Where Codex MRLs recognised/adopted

Regulatory Methodologies Negative Differing risk philosophies can impact chemical review & new chemistry assessment outcomes causing a disconnect Differing toxicological end points (ADI & ARfD) Differing residue definitions – residue trial data and MRLs don’t match between countries Positive Where JMPR recommendations accepted/adopted Accepting Codex MRLs Differing risk philosophies can impact chemical review & new chemistry assessments and outcomes (For example, the EU’s precautionary principle affects how they have viewed risk. This is what has been driving their move to hazard based regulatory system from the more common risk based approach) Differing toxicological end points – e.g., Different Health based guidance values (ADI & ARfD) At Codex, more frequently, a divergence in the tox end points between the EU and JMPR. Usually the EU levels are lower which means that they generally won’t accept the JMPR dietary exposure assessments and therefore the MRLs. Differing residue definitions (this can make confirming compliance problematic as residue trial data and MRLs don’t match between countries) There appears to be an increasing focus on minor metabolites and determining their significance, i.e., whether they need to be included in residue definitions. A pesticide can have multiple residue definitions, e.g., residue definitions can vary between plant and animal commodities and between definitions used for compliance and estimating dietary exposure. What can occur is that if different regulators have differing views on whether various metabolites should or should not be included it can create problems with transferability. By this I mean a residue that complies with the definition and MRL of an exporting country may not comply with the definition and MRL of the importing country. Then there is the issue of data transferability. If residue trial data is being generated to meet the residue definition on one regulator it may not meet the definition used by another. What impact may this have on data sharing from a minor use perspective? For new compounds this perhaps may not be a significant issue as registrants will have an incentive to try and cover any possible data gaps. However, for older generic compounds undergoing review, if questions arise about metabolites who will generate the data, the legacy registrants? Positive – Where JMPR recommendations accepted/adopted This could probably be rephrased to accepting Codex MRLs. From a grower industry perspective it’s a positive where countries have a clearly defined and transparent approach to accepting Codex MRLs. In effect by accepting Codex MRLs a country is accepting the JMPR recommendations in relation to health based guidance values, residue definitions, dietary exposure as well as the MRLs.

we hope to ensure a sustainable and productive industry By working together we hope to ensure a sustainable and productive industry for future generations. Thank you